MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1012453-20
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the 4.0x20mm nc trek balloon dilatation catheter (bdc) was used for post-dilatation of an unspecified stent; however, the balloon did not fully deflate and could not pulled back into the catheter.There was no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.
Event or Problem Description
Subsequently, after the initial report was filed it was noted that the balloon dilatation catheter (bdc) was removed with the entire system.Contrast ratio was 1 to 2.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional, and functional inspections were performed on the returned device.The reported deflation issue was not confirmed.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.The production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.It was reported that the contrast mix used in the procedure was 1 contrast | 2 serum.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global instructions for use (ifu) specified that the contrast is 60% contrast medium diluted 1:1 with normal saline.In this case, since 1 contrast to 2 serum ration was used and is less contrast concentration than the required percentage, it is unknown if the ifu violation caused or contributed to the reported complaint.Based on the reported information and results of the complaint investigation, there is no indication that the reported deflation issue or difficulty removing the device are related to a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported deflation issue since the compliant could not be confirmed during return analysis; however, the reported difficulty removing the device appear to be related to operational context.Possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.Additionally, returned device analysis noted that the balloon was folded inward at the distal end which likely contributed to the reported resistance met during removal.

• Brand Name: NC TREK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19726024
• Report Number: 2024168-2024-08196
• Device Sequence Number: 15462103
• Product Code: LOX
• UDI-Device Identifier: 08717648152085
• UDI-Public: (01)08717648152085(17)251231(10)30112G1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: 1012453-20
• Device Catalogue Number: 1012453-20
• Device Lot Number: 30112G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male